Randstad Clinical Operations in Durham, North Carolina

Clinical Operations


Durham, NC

Date Posted:

Wednesday, October 12, 2016

Job Type:


Reference #:



Randstad Life Sciences

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Job Title: TMF Specialist Project Leader

Position Description

  • Support global standards for Records Management activities.

  • Actively support activities associated with managing records within a global network of programs/systems for customers Trial Master File documents.

  • Serve as the liaison between Records Management and customers.

  • Supporting functional operational teams adhere to GCP records management and customer specific requirements, providing oversight of TMF management and developing a collaborative delivery of a quality TMF for our customers.

Position Responsibilities

  • Act as an SME for the file management process & all RIM Global management activities

  • Serve as TMF contact for documentation to Project team, cross functional departments to ensure high quality TMF deliverables are met on time.

  • Follow processes for set up, maintenance, and support for assigned TMF projects.

  • Monitor TMF throughout the study duration, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate.

  • Report TMF metrics trending and analysis as appropriate with resolution plans to proactively identify & avoid future issues

  • Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor

  • Follow applicable SOP s to ensure completeness & accuracy of TMF

  • Prepare/present TMF related information at internal meetings in a Globally consistent format

  • Provide support & involvement with internal quality or audit process s as relevant

  • Accountable for delivery of assigned TMF activities in accordance with project requirements & SLA s

  • Manage documentation associated with assigned clinical trials

  • Follow records management tasks, policies, and procedures

  • Conduct review documents with compliance to customer file plans and SOPs

  • SME on all designated Sponsor-specific TMF requirements (e.g. file format, process, export/shipping requirements)

  • Collaborates on TMF Quality for assigned sponsor trials

  • Reports TMF health findings at required frequency

  • Alert Project team and TMF Quality PM to any potential TMF Health issues

  • Provide regular updates on performance to SLAs

Position Requirements

  • Bachelor s degree and 3 years of related experience or equivalent combination of education, training and experience

  • In Depth/ Knowledge of and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

  • Working knowledge of regulations and guidance s relevant to the area of expertise

  • Knowledge of technology applications relevant to records management environments.

  • Strong software and computer skills, including MS Office applications.

  • Ability to establish and maintain effective working relationships with coworkers, managers,

  • Demonstrated ability to deliver results to the appropriate quality and timeline metrics.

  • Excellent communication, presentation and interpersonal skills

  • Good problem solving skills

  • An ability to demonstrate a critical eye & strong attention to detail

  • Ability to adapt quickly to a rapidly changing environment


  • Medical, Dental, and Vision Insurance

  • 401K Plan with Company Match

  • Life and AD&D Insurance

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